Boehringer Ingelheim launches phase 2 study of oral therapy for diabetic macular edema

(Image Credit: AdobeStock/SawBear Photography)

Boehringer Ingelheim recently announced the start of the THULITE phase II clinical study (NCT06962839). THULITE will evaluate the efficacy, safety, and tolerability of BI 1815368, an oral medication for the treatment of diabetic macular edema (DME).¹

Affecting more than 21 million people globally, DME is a leading cause of vision loss in people with diabetes. Current treatments for DME are limited, requiring frequent visits to a retina specialist for eye injections, and only addressing one eye at each visit.

This oral therapy would aim to prevent fluid leakage into the macula caused by DME, by reducing the permeability of newly formed blood vessels. Through oral administration, unlike current treatments, BI 1815368 would allow for the potential of at-home treatment, while also simultaneously addressing both eyes.

“An oral therapy for DME could represent a major step forward in its management,” said Charles C. Wykoff, MD, PhD, principal investigator of the trial, Director of Research, Retina Consultants of Texas and Chair of Research, Retina Consultants of America. “

A safe and effective systemic therapy would offer an important alternative to repeated intravitreal injections; it could enable more consistent initiation of care earlier in the disease process, improve treatment adherence and optimize quality of life for patients.”

“DME is one of the most challenging complications of diabetes, and as vision worsens, people may lose their independence and rely more on loved ones,” said Dario Madani, CEO at PRO RETINA, members of which serve on Boehringer’s DME Clinical Program Steering Committee.

“Patients and caregivers may have to balance work, family obligations and other diabetes complications, while managing their eye condition. We need treatment options that could reduce this burden.”

Part or Boehringer’s broader clinical program targeting diabetic retinal disease, BI 1815368 is the fourth investigational compound from Boehringer Ingelheim’s Eye Health portfolio to advance to a phase II clinical trial, a press release said. The broader program also includes BI 764524, which is currently being studies in the CRIMSON phase II trial (NCT06321302) for diabetic retinopathy.

“At Boehringer Ingelheim, we are working towards a future where earlier intervention leads to long-term outcomes that prevent vision loss. One way we aim to achieve this is by developing oral treatments, which offer patients the ability to be more in control of their condition,” said Patrick Bussfeld, MD, PhD, Global Head of Medicine, Eye Health at Boehringer Ingelheim.

“By targeting the disease pathway systemically, we also have the potential to prevent DME in one eye while the other is being treated.”

Reference:

1. Boehringer-ingelheim.com. Published 2025. Accessed July 7, 2025. https://www.boehringer-ingelheim.com/science-innovation/human-health-innovation/phase-ii-start-oral-treatment-diabetic-macular-edema